Strata Oncology will help Epizyme accelerate patient enrollment in the Phase 2 clinical trial assessing Epizyme’s EZH2 inhibitor tazemetostat in patients with relapsed or refractory non-Hodgkin lymphoma.
Strata is conducting an observational study to offer next-generation sequencing to all advanced cancer patients at affiliated cancer centers and hospitals. It refers patients with selected mutations to its pharmaceutical partners’ clinical trials.
The Strata Trial, launched December 2016, will provide free tumor sequencing to 100,000 patients, representing an unprecedented approach to increasing patient access to precision medicine and accelerating the development of emerging cancer therapies.
As part of its agreement with Epizyme, Strata will identify non-Hodgkin lymphoma patients with EZH2 activating mutations and refer them for potential enrollment in Epizyme’s ongoing Phase 2 trial.
“This collaboration with Epizyme exemplifies Strata’s commitment to selecting the most promising precision medicine programs for our portfolio of pharma-sponsored trials,” Dan Rhodes, PhD, CEO of Strata Oncology, said in a news release. “The addition of tazemetostat to Strata’s growing portfolio of programs furthers our goal of providing cancer patients with greater access to clinical trials specific to their cancer type.”
The EZH2 protein is part of a protein complex that inserts epigenetic modifications in the DNA, thereby modulating the expression of a given set of genes. Overactivation of this protein in non-Hodginks lymphoma patients is known to be associated with cancer development. Tazemetostat is a first-in-class, highly selective EZH2 inhibitor.
Epizyme’s study (NCT01897571) is a multicenter, open-label Phase 1/2 study conducted in two parts. The Phase 1 portion was a dose-escalation study to establish the recommended Phase 2 dose of oral, twice-daily tazemetostat in patients with advanced solid tumors and B-cell lymphomas.
Data presented June 2016 at the AHS Lymphoma showed durable responses and an acceptable safety profile in non-Hodgkin lymphoma — with or without EZH2 mutations — and solid tumors.
The Phase 2 portion of the study, now enrolling patients with diffuse large B-cell lymphoma and follicular lymphoma, will assess the safety and efficacy of tazemetostat in five separate cohorts, stratified according to cell-of-origin and EZH2 mutation status.
Initial efficacy data from this part of the study, also presented at the 2016 AHS Lymphoma, has shown that out of 47 patients evaluable for efficacy, four achieved a complete response, nine achieved a partial response, and 13 exhibited stable disease. That translates into an objective response rate of 28 percent and a disease control rate of 55 percent.
